CytomegalovirusNCT00668798
Cytomegalovirus (CMV) Transmission by Frozen Breast Milk in Preterms
An observational study of Cytomegalovirus, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial summary
Cytomegalovirus infection threatens preterm infant. We investigated, whether thawed breast milk is a mode of transmission Read more about this study
- Who is it for?
- Ages 24 to 31 weeks
- Conditions the study is for
- Cytomegalovirus
- How many people
- 58 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2005to Mar 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 31 weeks
- All sexes
- No healthy volunteers
- Child
Study population: preterm infants of less than 32 weeks of gestation
Who may be able to join
- preterm infants of less than 32 weeks of gestation
Who cannot join
- preterm infant of 32 weeks of gestational age or older, feeding with solely formula milk
- ourborn infants
- retroviral infection
- CMV status of mother unclear
- informed consent missing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence and Clinical Outcome of Human Cytomegalovirus Transmission Via Thawed Frozen Breast Milk in Preterm Infants <31 Weeks. A Prospective Trial.
Cytomegalovirus infection threatens preterm infant. We investigated, whether thawed breast milk is a mode of transmission
Read the detailed description
Preterm infants are at risk of symptomatic human cytomegalovirus infections transmitted by breast milk. This study evaluates incidence, timing, and clinical rlevance of acquired human CMV infections in preterm infants younger than 32 weeks of gestational age receiving maternal thawed frozen breast milk until 33 completed weeks of gestational age.
- Conditions
- Cytomegalovirus
- Keywords
- cytomegalovirus breast milk preterm infants transmission, transmission of CMV via thawed frozen breast milk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| A | mother CMV positive | |
| B | mother CMV negative |
What is being measured
The primary outcome is the main question the study is designed to answer.
CMV status of preterm infants
Measured: 2005-2008
Secondary outcomes (1)
clinical manifestations of CMV infection
Measured: 2005-2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2008 (estimated)
- Study startJan 2005
- Primary completionJan 2008 (estimated)
- Study completionMar 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CytomegalovirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Karl Bauer, Professor, Principal investigator, Goethe University, Dpt of Neonatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00668798
- Sponsor's protocol ID
- CMV/MM0105/FFM
- Status last verified
- Apr 2008
- First submitted
- 25 Apr 2008
- Last updated
- 29 Apr 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Hamprecht K, Maschmann J, Vochem M, Dietz K, Speer CP, Jahn G. Epidemiology of transmission of cytomegalovirus from mother to preterm infant by breastfeeding. Lancet. 2001 Feb 17;357(9255):513-8. doi: 10.1016/S0140-6736(00)04043-5.
PubMed 11229670
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Clinical Outcome of Human Cytomegalovirus Transmission Via Thawed Frozen Breast Milk in Preterm Infants <31 Weeks. A Prospective Trial.
- ClinicalTrials.gov ID
- NCT00668798
- Acronym / sponsor ID
- CMV/MM0105/FFM
- Conditions
- Cytomegalovirus
- Keywords
- cytomegalovirus breast milk preterm infants transmission, transmission of CMV via thawed frozen breast milk
- Study type
- Observational
- Recruitment status
- Suspended
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Jan 2008 (estimated)
- Study completion
- Mar 2008 (estimated)
- First posted
- 29 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cytomegalovirus infection threatens preterm infant. We investigated, whether thawed breast milk is a mode of transmission
Detailed description
Preterm infants are at risk of symptomatic human cytomegalovirus infections transmitted by breast milk. This study evaluates incidence, timing, and clinical rlevance of acquired human CMV infections in preterm infants younger than 32 weeks of gestational age receiving maternal thawed frozen breast milk until 33 completed weeks of gestational age.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | –mother CMV positive |
| B | – | –mother CMV negative |
Who may qualify
- Ages
- 24 to 31 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- preterm infants of less than 32 weeks of gestation
Key inclusion criteria (1 listed)
- preterm infants of less than 32 weeks of gestation
Key exclusion criteria (5 listed)
- preterm infant of 32 weeks of gestational age or older, feeding with solely formula milk
- ourborn infants
- retroviral infection
- CMV status of mother unclear
- informed consent missing
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
CMV status of preterm infants
Time frame: 2005-2008
1 secondary outcome
clinical manifestations of CMV infection
Time frame: 2005-2008
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2008.
- Background: PubMed 11229670Hamprecht K, Maschmann J, Vochem M, Dietz K, Speer CP, Jahn G. Epidemiology of transmission of cytomegalovirus from mother to preterm infant by breastfeeding. Lancet. 2001 Feb 17;357(9255):513-8. doi: 10.1016/S0140-6736(00)04043-5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karl Bauer, Professor principal investigator
Goethe University, Dpt of Neonatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cytomegalovirus, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 29 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CMV status of preterm infants (time frame: 2005-2008). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00668798, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2008.